Senior Manager, Early Clinical Development & Experimental Sciences
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Qualified scientist with training in the pharmaceutical/biotechnology sector, or academic or clinical setting. Works independently with minimal supervisor oversight, leads other members of the cross-functional team, contributes to early development and clinical experimentation for projects for discovery phase through Proof of Concept (POC).
Supports the cross-functional study team on the following activities, including but not limited to:
â€¢ Facilitates/Leads the writing of Clinical Study Concepts (CSCs) and Clinical Study Protocols (CSPs) and amendments.
o Identifies key internal and external collaborators/advisors, organizes and conducts consultations with global subject matter experts
â€¢ Represents the clinical ECD&ES function on clinical study teams, contributing medical/scientific knowledge to timely and compliant clinical trial execution and quality of deliverables:
o Works alongside Clinical Trial Manager to provide day-to-day clinical input to the study team
o Drafts and review clinical sections in regulatory and clinical documents such as: regulatory agency briefing books, IND/IMPD submissions, investigatorâ€™s brochure, informed consent forms, IRB/IEC submissions, clinical study reports, abstracts/manuscripts for publication, etc.
o Reviews study related documents such as: medical monitoring plans, statistical analysis plans, data management plan, eCRF completion guidelines, data validation manuals, database UAT, etc
o Trains and support study team and CRO personnel regarding clinical aspects of trial
o Accountable to the Clinical Lead for the project for a specific trial for: first-line medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety and efficacy, etc.
o Maintains and develops relationship with key study investigators, organizes steering committees, advisory boards, and data safety monitoring boards as required
o Identifies program, trial or data risks, creates and implements mitigation strategies
o Ensures Clinical Team compliance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
o Demonstrates capability to supervise and mentor less experienced personnel.
â€¢ Provides background literature searches and contributes to the design of :
o Early clinical strategy in terms of indication selection, study rationale, scientific/clinical endpoints
o POC-enabling human studies, First-In-Human (FIH) studies, clinical experimental studies as per clinical strategy
â€¢ Bachelorâ€™s degree. Ph.D., PharmD. or Masters degree in biomedical subject, preferred
â€¢ 6-8 years of clinical research/development experience, preferred.
â€¢ Effective communications (verbal & written) and presentation skills are essential.
â€¢ Must be able to work productively in a fast-paced collaborative environment.
â€¢ Demonstrated/potential for critical thinking skills and sound decision-making.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneronâ€™s unwavering commitment to combining good science & good business.
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Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.